Systematic digital framework for optimizing changeover cleaning in pharmaceutical industries

A generalized and systematic framework for optimizing the changeover cleaning process in pharmaceutical manufacturing has been developed, with its application demonstrated in various scenarios to facilitate better decision-making regarding cleaning. This framework enhances cleaning decision-making by incorporating detailed modeling of various cleaning mechanisms tailored to common vessel configurations and cleaning modes prevalent in the industry. By extending the approach to entire process flowsheets comprising multiple unit operations, the framework proves effective in quantifying and demonstrating rational utilization of washing solvents and better non-productive downtime management associated with cleaning activities. The comprehensive analysis yields insights for the identification of optimal cleaning conditions that achieve regulatory cleanliness standards while minimizing operational cleaning costs by approximately up to 91% and environmental footprint quantified in terms of reduction in washing solvent consumption by approximately up to 87% when cleaned in the hybrid mode compared to cleaning all the unit operations in the same mode (i.e. either batch or continuous mode of cleaning). Overall, the proposed integrative methodology supports informed decision-making toward greener, cost-effective, and operationally efficient cleaning strategies at the flowsheet level. • Generalized framework for changeover cleaning in pharmaceutical industries. • Optimal cleaning conditions for minimized cleaning costs identified. • Comparison of cleaning using solvent versus a single-use reactor. • Solvents ranked by cleaning cost and environmental footprint for informed selection. • Flowsheet-level optimization enables cutting solvent use by up to 87%.